If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Gliclazide Side Effects Reported to FDA

The following Gliclazide reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

The appearance of Gliclazide on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Hepatitis Fulminant

This is a report of a 85-year-old female patient (weight: NA) from FR, suffering from the following symptoms/conditions: NA, who was treated with Gliclazide (dosage: 30 Mg, Daily, start time: Aug 25, 2013), combined with:

Metformin Hydrochloride (1 Df, Daily)

and developed a serious reaction and side effect(s). The consumer presented with:

Hepatitis Fulminant

which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gliclazide treatment in female patients, resulting in hepatitis fulminant side effect.

Lactic Acidosis, Renal Failure Acute, Dehydration

This report suggests a potential Gliclazide Lactic Acidosis, Renal Failure Acute, Dehydration side effect(s) that can have serious consequences. A 86-year-old female patient (weight: NA) from CN was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Gliclazide (dosage: Modified-release Formulation) starting NS. Soon after starting Gliclazide the patient began experiencing various side effects, including:

Lactic Acidosis

Renal Failure Acute

Dehydration

Drugs used concurrently:

Metformin Hydrochloride

Polyethylene Glycol

The patient was hospitalized. Although Gliclazide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as lactic acidosis, may still occur.

Hypoglycaemia

This Hypoglycaemia problem was reported by a consumer or non-health professional from IT. A 84-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On Oct 10, 2013 this consumer started treatment with Gliclazide (gliclazide) (dosage: NA). The following drugs were being taken at the same time:

Clarithromycin (clarithromycin)

Nebivolol (nebivolol) ?

Lercanidipine (lercanidipine) ?

Enalapril

Glyceryl Trinitrate (glyceryl Trinitrate)

Paracetamol (paracetamol)?

Cardioaspirin (acetylsalicylic Acid)

Amoxicillin (amoxicillin)

When commencing Gliclazide (gliclazide), the patient experienced the following unwanted symptoms/side effects:

Hypoglycaemia

Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as hypoglycaemia, may become evident only after a product is in use by the general population.

International Normalised Ratio Decreased

This is a report of a 72-year-old female patient (weight: NA) from GB. The patient developed the following symptoms/conditions: diabetes mellitus and was treated with Gliclazide (dosage: 80 Milligram Daily;) starting Jan 29, 2013. Concurrently used drugs:

Warfarin

Ramipril

Simvastatin

Metformin

Bendroflumethiazide

Atenolol

Soon after that, the consumer experienced the following side effects:

International Normalised Ratio Decreased

This opens a possibility that Gliclazide treatment could cause the above reactions, including international normalised ratio decreased, and some female subjects may be more susceptible.

Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Gliclazide.

Hypoglycaemia, Weight Increased, Angina Pectoris

A 74-year-old female patient from HU (weight: NA) experienced symptoms, such as: type 2 diabetes mellitus and was treated with Gliclazide(dosage: 120 Mg, Daily). The treatment was initiated on NS. After that a consumer reported the following side effect(s):

Hypoglycaemia

Weight Increased

Angina Pectoris

Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Gliclazide efficacy: NA.

International Normalised Ratio Decreased

In this report, Gliclazide was administered for the following condition: diabetes mellitus.A 72-year-old female consumer from GB (weight: NA) started Gliclazide treatment (dosage: 80 Mg, Qd) on Jan 29, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):

International Normalised Ratio Decreased

A possible interaction with other drugs could have contributed to this reaction:

Warfarin

Ramipril

Simvastatin

Metformin

Bendroflumethiazide

Atenolol

Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Gliclazide treatment could be related to the listed above side effect(s).

Joint Swelling, Rheumatoid Arthritis, Palindromic Rheumatism

This is a report of the following Gliclazide side effect(s):

Joint Swelling

Rheumatoid Arthritis

Palindromic Rheumatism

A 56-year-old male patient from GB (weight: NA) presented with the following condition: NA and received a treatment with Gliclazide (dosage: 160mg Morning, 80mg Evening) starting: NS.The following concurrently used drugs could have generated interactions:

Metformin

Omeprazole

Ramipril

Sitagliptin

Citalopram

Methotrexate

Folic Acid

This report suggests that a Gliclazide treatment could be associated with the listed above side effect(s).

Mitral Valve Incompetence, Aortic Valve Incompetence, Fluid Retention

This Gliclazide report was submitted by a 50-year-old female consumer from IN (weight: NA). The patient was diagnosed with: type 2 diabetes mellitus and Gliclazide was administered (dosage: 160 Mg, Daily) starting: NS. The consumer developed a set of symptoms:

Mitral Valve Incompetence

Aortic Valve Incompetence

Fluid Retention

Other drugs used simultaneously:

Metformin Hydrochloride (Unk)

Pioglitazone (15 Mg, Daily)

Pioglitazone (30 Mg, Dailly)

Sitaglipin (100 Mg, Unk)

Those unexpected symptoms could be linked to a Gliclazide treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

A 58-year-old female patient from GB (weight: NA) presented with the following symptoms: diabetes mellitus and after a treatment with Gliclazide (dosage: Unk) experienced the following side effect(s):

Cerebral Haematoma

The treatment was started on May 14, 2012. Gliclazide was used in combination with the following drugs:

Levothyroxine (Unk)

Metformin (Unk)

Montelukast (Unk)

Ramipril (Unk)

Simvastatin (Unk)

Spironolactone (Unk)

Warfarin (Unk)

Victoza (1.2 Mg, Qd)

The patient was hospitalized.This report could alert potential Gliclazide consumers.

Liver Function Test Abnormal

In this report, a 69-year-old female patient from (weight: NA) was affected by a possible Gliclazide (gliclazide) side effect.The patient was diagnosed with NA. After a treatment with Gliclazide (gliclazide) (dosage: NA, start date: May 29, 2012), the patient experienced the following side effect(s):

Liver Function Test Abnormal

The following simultaneously used drugs could have led to this reaction:

Simvastatin

Tramadol Hcl

Trimethoprim

Alendronic Acid(alendronic Acid)

Gabapentin

Amitriptyline Hcl

Diazepam

Eplerenone

The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Gliclazide (gliclazide) treatment.

This is a report of a 36-year-old female patient from UNITED KINGDOM (weight: NA), who used Gliclazide (dosage: NA) for a treatment of type 2 diabetes mellitus. After starting a treatment on NS, the patient experienced the following side effect(s):

Aphasia

Cerebrovascular Accident

Metabolic Disorder

Obesity

Hypertension

Hemiparesis

The following drugs could possibly have interacted with the Gliclazide treatment

Insulin

Rosiglitazone

Metformin Hcl

Taken together, these observations suggest that a Gliclazide treatment could be related to side effect(s), such as Aphasia, Cerebrovascular Accident, Metabolic Disorder, Obesity, Hypertension, Hemiparesis.

Cholelithiasis, Cholecystitis Acute

This cholelithiasis side effect was reported by a physician from FRANCE. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus. The patient was prescribed Gliclazide (dosage: NA), which was started on Apr 04, 2010. Concurrently used drugs:

Aspirin Lysine

Janumet

Perindopril Arginine

Repaglinide

Metformin Pamoate

Januvia

When starting to take Gliclazide the consumer reported the following symptoms:

Cholelithiasis

Cholecystitis Acute

The patient was hospitalized. These side effects may potentially be related to Gliclazide.

This is a Gliclazide side effect report of a 71-year-old male patient (weight:NA) from FRANCE, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Gliclazide (dosage:NA, start time: Jan 01, 2008), combined with:

Allopurinol

Januvia

Insulin Glargine

, and developed a serious reaction and a pancreatitis chronic side effect. The patient presented with:

Pancreatitis Chronic

Pancreatitis Necrotising

Pancreatic Neoplasm

Pancreatitis Acute

which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Gliclazide treatment in male patients suffering from type 2 diabetes mellitus, resulting in pancreatitis chronic.

This report suggests a potential Gliclazideloss of consciousness side effect(s) that can have serious consequences. A 7-year-old male patient from UNITED KINGDOM (weight:NA) was diagnosed with the following health condition(s): NA and used Gliclazide (dosage: NA) starting NS. Soon after starting Gliclazide the patient began experiencing various side effects, including:

Loss Of Consciousness

Diarrhoea

Duodenal Ulcer Haemorrhage

Faeces Discoloured

Gastrointestinal Haemorrhage

Syncope

Pallor

Drugs used concurrently:

Amlodipine

Lisinopril

Pradaxa (150 Mg)

Aspirin

Metformin Hcl

Bisoprolol

Flucloxacillin

Metronidazole

The patient was hospitalized. Although Gliclazide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as loss of consciousness, may still occur.

Hepatic Enzyme Increased

This hepatic enzyme increased problem was reported by a health professional from SOUTH AFRICA. A 32-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Mar 13, 2012 a consumer started treatment with Gliclazide (dosage: 80 Mg, Bid). The following drugs/medications were being taken at the same time:

Moxifloxacin (Unk)

Moxifloxacin (400 Mg, Qd)

Ethionamide (750 Mg, Qd)

Kanamycin (1 G, Qd)

Metformin Hcl (1 G, Bid)

Ethambutol Hydrochloride (12 G, Qd)

Tropicamide (8 Gtt, Unk)

Metformin Hcl (500 Mg, Bid)

When commencing Gliclazide, the patient experienced the following unwanted symptoms /side effects:

Hepatic Enzyme Increased

The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as hepatic enzyme increased, may become evident only after a product is in use by the general population.

Acute Febrile Neutrophilic Dermatosis, Eosinophilia

This is a Gliclazide side effect report of a 64-year-old male patient (weight: NA) from FRANCE. The patient developed the following symptoms/conditions: NA and was treated with Gliclazide (dosage: NA) starting Feb 27, 2012. Concurrently used drugs:

Medrol (Unk)

Clarithromycin (Unk)

Amlodipine

Innovar (Unk)

Januvia

Nexium

Fluticasone Propionate/salmeterol

Levemir

Soon after that, the consumer experienced the following of symptoms:

Acute Febrile Neutrophilic Dermatosis

Eosinophilia

The patient was hospitalized. This opens a possibility that Gliclazide could cause acute febrile neutrophilic dermatosis and that some male patients may be more susceptible.

Diabetic Nephropathy

A 80-year-old male patient (weight: NA) from FRANCE with the following symptoms: NA started Gliclazide treatment (dosage: NA) on Jan 01, 2000. Soon after starting Gliclazide treatment, the consumer experienced several side effects, including:

Diabetic Nephropathy

. Concurrently used drugs:

Ramipril

Metformin Pamoate

This finding indicates that some patients can be more vulnerable to developing Gliclazide side effects, such as diabetic nephropathy.

Cerebral Infarction, Hemiplegia

This cerebral infarction side effect was reported by a physician from AUSTRALIA. A male patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus,colon cancer metastatic.The patient was prescribed Gliclazide (dosage: NA), which was started on May 16, 2012. Concurrently used drugs:

Xeloda

Metformin Hcl

Panadol Osteo

Lipitor

Irinotecan Hcl

.When starting to take Gliclazide the consumer reported symptoms, such as:

Cerebral Infarction

Hemiplegia

These side effects may potentially be related to Gliclazide.

Hospitalisation

This is a report of a female patient (weight: NA) from FRANCE, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Gliclazide (dosage: NA, start time: Dec 14, 2009), combined with:

Acarbose

Januvia

Metformin Hcl

and developed a serious reaction and side effect(s). The consumer presented with:

Hospitalisation

which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gliclazide treatment in female patients, resulting in hospitalisation side effect. The patient was hospitalized.

Jaundice Cholestatic

This report suggests a potential Gliclazide Jaundice Cholestatic side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from UNITED KINGDOM was diagnosed with the following symptoms/conditions: NA and used Gliclazide (dosage: NA) starting Mar 19, 2012. Soon after starting Gliclazide the patient began experiencing various side effects, including:

Jaundice Cholestatic

Drugs used concurrently:

Levothyroxine Sodium

Tadalafil

Bendroflumethiazide

Metformin

Tramadol Hydrochloride

Amlodipine

Acetaminophen

Losartan Potassium

The patient was hospitalized. Although Gliclazide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as jaundice cholestatic, may still occur.

Large Intestine Perforation

This Large Intestine Perforation problem was reported by a consumer or non-health professional from CANADA. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On Jun 22, 2010 this consumer started treatment with Gliclazide (dosage: NA). The following drugs were being taken at the same time:

Calcium Carbonate

Pantoprazole

Mabthera (Day 1 And Day 15)

Cephalexin

Latanoprost

Lyrica

Prednisone Tab

Brimonidine Tartrate

When commencing Gliclazide, the patient experienced the following unwanted symptoms/side effects:

Large Intestine Perforation

Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as large intestine perforation, may become evident only after a product is in use by the general population.

Oedema, Oedema Peripheral, Mobility Decreased

This is a report of a 64-year-old male patient (weight: NA) from UNITED KINGDOM. The patient developed the following symptoms/conditions: NA and was treated with Gliclazide (dosage: NA) starting Mar 06, 2011. Concurrently used drugs:

Metformin

Perindopril

Amlodipine

Januvia

Soon after that, the consumer experienced the following side effects:

Oedema

Oedema Peripheral

Mobility Decreased

This opens a possibility that Gliclazide treatment could cause the above reactions, including oedema, and some male subjects may be more susceptible.

Top 10 Gliclazide Side Effects for Men

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

You can use them to remind you of details that may alert your health care professional(s) to a problem

You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

Log Form

You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

Medicine Name and Dosage:

Side Effects

Scale

Date & Time

Other Medicine(s) or Treatment(s)

Scale: 1 = very mild to 10 = very bad

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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